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Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)

Novartis Pharmaceuticals · 2025
ClinicalTrials.gov · Datasets · License: Public Domain · 2025
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The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety 1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response \[CRR\] or partial renal response \[PRR\]) on double-blind treatment at the end of the SIRIUS-LN core study, and 2. of open-label ianalumab 300 mg treatment in patients who, at the end of the SIRIUS-LN core study, were either already receiving ianalumab open-label treatment or did not meet CRR/PRR criteria on double-blind treatment at the end of the SIRIUS-LN core study.
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